5 and 10 mg Donepezil as well as 4 and 8 mg Ondansetron are under final development using the proprietary RapidFilm drug delivery Technology securing fast dissolution in the oral cavity without the need of water

RapidFilm is a novel proprietary formulation consisting of a polymeric film strip dissolving quickly without any need of water and releasing the drug in the oral cavity.

Under the terms of the Joint Venture Agreement between the two drug delivery companies Labtec GmbH of Germany (Labtec) and APR Applied Pharma Research s.a. of Switzerland (APR) Donepezil RapidFilm and Ondansetron RapidFilm are currently under final development.Labtec and APR are currently completing full development of new oral formulations. Donepezil RapidFilm is generic to ARICEPT® ODT marketed in Europe as well as in the US by Eisai and Pfizer. Ondansetron RapidFilm is generic to ZOFRAN® Zydis Lingual ODT (Oral Dispersible Tablet) marketed in Europe as well as in the US by Glaxo Smith Kline. Both use the proprietary RapidFilm® technology which is a novel, non-mucoadhesive, fast dissolving oral dosage form based on a water soluble polymer. The film disintegrates rapidly within seconds in contact with saliva, releases the drug in the oral cavity and promotes gastrointestinal absorption, which is comparable to immediate release oral solid dosage forms. The RapidFilm® dosage form was especially designed for higher patient compliance. The application is easy. The patient does not face any swallowing difficulty. The fact that no water intake after administration is needed is very well accepted by patients with nausea.The products are packed in a specially designed proprietary packaging system named RapidCard.For the Donepezil RapidFilm the dossier completion and submission for approval is expected in Q2/2008 and Marketing Authorization in Q4/2009. The product will be registered as generic of Aricept.For the Ondansetron RapidFilm the dossier completion and submission is expected in Q3/2007; approval is expected sometime in 2008. The product will be registered as generic of Zofran ODT. Internal evaluations suggests that RapidFilm can offer multiple competitive advantages over Zydis technology such as manufacturing costs, innovation, etc. so enabling RapidFilm to even successfully compete in a generic environment. 

Phase I/II

Patents pending on both technology and packaging

Both products are available for Licensing wherever Donepezil and Ondansetron are off-patents. We are looking for licensing both RapidFilms at European or Worldwide level.